ROWASA Drug Patent Profile

When do Rowasa patents expire, and when can generic versions of Rowasa launch?

Rowasa is a drug marketed by Mylan Speciality Lp and Meda Pharms and is included in two NDAs.

The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rowasa

A generic version of ROWASA was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for ROWASA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	3
Patent Applications:	4,159
Drug Prices:	Drug price information for ROWASA
What excipients (inactive ingredients) are in ROWASA?	ROWASA excipients list
DailyMed Link:	ROWASA at DailyMed

See drug prices for ROWASA

Recent Clinical Trials for ROWASA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Colitis & Crohn's Foundation (India)	Phase 3
Dayanand Medical College and Hospital	Phase 3
Altheus Therapeutics, Inc.	Phase 1

See all ROWASA clinical trials

Pharmacology for ROWASA

Drug Class

Aminosalicylate

US Patents and Regulatory Information for ROWASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	AB	RX	Yes	Yes
Meda Pharms	ROWASA	mesalamine	SUPPOSITORY;RECTAL	019919-001	Dec 18, 1990		DISCN	Yes	No

Expired US Patents for ROWASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987

International Patents for ROWASA

See the table below for patents covering ROWASA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2567068
Spain	2026179
Israel	81799	PACKAGED PHARMACEUTICAL COMPOSITION CONTAINING BISULFITE STABILIZED SOLUTION OF 5-AMINOSALICYCLIC ACID AND METHODS FOR THE PREPARATION THEREOF
Germany	3773657
Australia	2008211124	Improved reduced irritant enema for the treatment of Inflammatory Bowel Disease (IBD)

ROWASA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ROWASA (Mesalamine)

Introduction to ROWASA

ROWASA, a brand name for the drug mesalamine, is an aminosalicylate used primarily for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis in adults. Here, we delve into the market dynamics and financial trajectory of ROWASA, highlighting key drivers, challenges, and opportunities.

Market Drivers

Increasing Prevalence of Inflammatory Bowel Diseases (IBD)

The rising global prevalence of IBD, including ulcerative colitis and Crohn's disease, is a significant driver for the mesalamine market. As more people are diagnosed with these conditions, the demand for effective treatments like ROWASA increases[1].

Technological Advancements in Drug Formulation

Advancements in drug formulation have enhanced the efficacy and patient compliance of mesalamine. Extended-release and combination therapies are being developed to improve therapeutic outcomes and reduce side effects, making ROWASA more appealing to both patients and healthcare providers[1].

Growing Awareness of Gastrointestinal Health

Increased awareness about gastrointestinal health and the importance of managing IBD has boosted the preference for mesalamine treatments. This growing awareness is driven by public health campaigns and educational initiatives, contributing to the market growth of ROWASA[1].

Market Restraints

Adverse Side Effects

Despite its efficacy, mesalamine is associated with several adverse reactions, including gas, flu, fever, leg/joint pain, and more severe conditions like myocarditis and pericarditis. These side effects can limit its adoption and affect patient compliance[3].

Alternative Therapies

The availability of alternative treatments for IBD poses a competitive threat to ROWASA. Other medications and therapies may offer similar or better outcomes, potentially diverting market share away from mesalamine[1].

Regulatory Requirements

Stringent regulatory requirements can slow down the approval process for new formulations and indications of mesalamine. This regulatory landscape must be navigated carefully to ensure compliance and market access[1].

Market Opportunities

Emerging Markets and Healthcare Infrastructure

Emerging markets with growing healthcare expenditure and investment in R&D offer significant opportunities for the mesalamine market. Expanding healthcare infrastructure in these regions can increase access to ROWASA and other mesalamine products[1].

Digital Health Integration

Leveraging telemedicine and digital health platforms can facilitate easier access and adherence to mesalamine treatments. Integrating digital health technologies for monitoring and managing IBD can provide comprehensive care solutions and enhance patient outcomes[1].

Combination Therapies

Introducing mesalamine-based combination therapies can address a broader range of gastrointestinal disorders, expanding the market potential of ROWASA. These combination therapies can offer more comprehensive treatment options for patients with complex IBD conditions[1].

Financial Trajectory

Revenue Growth

The mesalamine market, including ROWASA, is experiencing revenue growth driven by increasing demand and advancements in drug formulations. The market size is projected to grow significantly over the forecast period, with the capsule segment expected to account for a noticeable share of the global mesalamine market[4].

Pharmaceutical Company Performance

Companies like Allergan and Nogra Pharma, which are involved in the production and distribution of mesalamine, are focusing on strategic collaborations, acquisitions, and product innovation to enhance their market position. These efforts are reflected in their financial performance, with many reporting increased revenue and adjusted EBITDA margins[4].

Example: Tabula Rasa HealthCare

While not directly related to ROWASA, the financial performance of healthcare companies like Tabula Rasa HealthCare (TRHC) provides insights into the broader healthcare market trends. TRHC reported strong organic revenue growth of 24% in the second quarter of 2023, with adjusted EBITDA increasing more than three times compared to the same period in 2022. This growth is indicative of the overall health and potential of the pharmaceutical and healthcare services sector[5].

Competitive Landscape

The mesalamine market is competitive, with both established pharmaceutical companies and emerging players vying for market share. Strategic collaborations, acquisitions, and product innovation are key strategies employed by these companies to stay competitive. The presence of generic versions of mesalamine, following patent expirations, also adds to the competitive dynamics, making the market more accessible and cost-effective for patients[1].

Patient-Centric Approaches

Focusing on patient-centric approaches and personalized medicine is crucial for the development of customized mesalamine regimens. This approach can bolster patient compliance and therapeutic outcomes, making ROWASA and other mesalamine products more appealing to healthcare providers and patients alike[1].

Regulatory Considerations

Renal Impairment and Monitoring

The use of ROWASA requires careful evaluation of renal function prior to initiation and periodically during therapy. Patients with known renal impairment or a history of renal disease are at a higher risk of toxic reactions, highlighting the need for close monitoring[3].

Geriatric Use

Clinical trials have suggested a higher incidence of blood dyscrasias in patients aged 65 years and older receiving mesalamine-containing products. This necessitates careful consideration and monitoring of complete blood cell counts and platelet counts in this patient population[3].

Key Takeaways

• Growing Demand: The increasing prevalence of IBD and advancements in drug formulations drive the demand for mesalamine.
• Competitive Market: The market is competitive with established and emerging players, and the presence of generic versions adds to the dynamics.
• Regulatory Considerations: Stringent regulatory requirements and the need for careful patient monitoring are critical factors.
• Digital Health Integration: Leveraging digital health technologies can enhance patient outcomes and market access.
• Patient-Centric Approaches: Focusing on personalized medicine can improve therapeutic outcomes and patient compliance.

FAQs

What is ROWASA used for?

ROWASA (mesalamine) is used for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis in adults.

What are the common side effects of ROWASA?

Common side effects include gas, flu, fever, leg/joint pain, and more severe conditions like myocarditis and pericarditis.

How does the competitive landscape of the mesalamine market look?

The market is competitive with established pharmaceutical companies and emerging players, and the presence of generic versions following patent expirations adds to the competitive dynamics.

What are the key opportunities for the mesalamine market?

Key opportunities include emerging markets, digital health integration, and the development of combination therapies.

Why is patient monitoring important for ROWASA?

Patient monitoring is crucial, especially for renal function and in geriatric patients, due to the risk of toxic reactions and blood dyscrasias.

Sources

1. 360iResearch: Mesalamine Market Size & Share 2025-2030
2. Tabula Rasa HealthCare: Fourth Quarter and Full Year 2021 Financial Results
3. FDA: ROWASA (mesalamine) rectal suspension - Highlights of Prescribing Information
4. Cognitive Market Research: Mesalamine Market Report 2024 (Global Edition)
5. Tabula Rasa HealthCare: Second Quarter 2023 Financial Results